Clinical Research Acronyms and Abbreviations You Should Know

We all know there are numerous acronyms and abbreviations used in clinical research. While some can be easily deciphered, others may take some searching to find their meaning. Particularly with the recent surge in electronic systems and regulations, it can be hard to keep track of necessary abbreviations and terms.

Whether you’re new to the clinical research world or need a refresher, here’s a condensed list of common acronyms and abbreviations you may come across.

AACI: Association of American Cancer Institutes

AAHRPP: Association for the Accreditation of Human Research Protection Programs

ABSA: Association of Biosafety and Biosecurity

ACRP: Association of Clinical Research Professionals

ACTS: Association for Clinical and Translational Science

ADME: Absorption, Distribution, Metabolism, and Elimination

ADR: Adverse Drug Reaction

AE: Adverse Event

ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate

AMC: Academic Medical Center

API: Active Pharmaceutical Ingredient

API: Application Program Interface

ARO: Academic Research Organization

ASCO: American Society of Clinical Oncology

ASCPT: American Society for Clinical Pharmacology and Therapeutics

ASGCT: American Society of Gene & Cell Therapy

BA/BE: Bioavailability/Bioequivalance

BLA: Biological Licensing Application

BSM: Biospecimen Management

caBIG: Cancer Biomedical

CAPA: Corrective and Preventive Action

CAR-T: Chimeric Antigen Receptors and T cells

CBER: Center for Biologics Evaluation and Research

CBRN: California Board of Registered Nursing

CCEA: Complete, Consistent, Enduring, Available

CCOP: Community Clinical Oncology Program

CCR: Center for Cancer Research

CCSG: Cancer Center Support Grant

CCTO or CTO: Centralized Clinical Trials Office or Clinical Trials Office

CDASH: Clinical Data Acquisition Standards Harmonization

CDER: Center for Drug Evaluation and Research

CDM: Clinical Data Management

Related article: “Improve Data Quality with 5 Fundamentals of Clinical Data Management”

CDP: Clinical Development Plan

CDRH: Center for Devices and Radiological Health

CDS: Clinical Data System

CDUS: Clinical Data Update System

CFR: Code of Federal Regulations

CMO: Contract Manufacturing Organization

CMS: Centers for Medicare & Medicaid Services

CRA: Clinical Research Associate

CRC: Clinical Research Coordinator

Related article: “Deciphering the CRC Career Path: Key Skills and Responsibilities”

CRF: Case Report Form

CRMS: Clinical Research Management System

CRO: Contract Research Organization

CRPC: Clinical Research Process Content

CSO: Contract Safety Organization

CSR: Clinical Study Report

CTA: Clinical Trial Authorization

CTCAE: Common Terminology Criteria for Adverse Events

CTMS: Clinical Trial Management System

CTRP: Clinical Trials Reporting Program

CTSA: Clinical and Translational Science Award

DDI: Drug-Drug Interaction

DHHS: Department of Health and Human Services

DM: Data Manager

DMC: Data Monitoring Committee

DSMB: Data and Safety Monitoring Board

EC: Ethics Committee

eCOA: Electronic Clinical Outcome Assessment

eCRF: Electronic Case Report Form

EDC: Electronic Data Capture

Learn more about Advarra’s electronic data capture system, Advarra EDC.

EHR: Electronic Health Record

EMR: Electronic Medical Record

ePRO: Electronic Patient-Reported Outcomes

eTMF: Electronic Trial Master File

FAIR: Findable, Accessible, Interoperable, Reusable

FDA: Food and Drug Administration

FE: Food Effect

FIH: First In Human

FWA: Federalwide Assurance

GCP: Good Clinical Practice

GCRC: General Clinical Research Center

GDP: Good Documentation Practice

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GVP: Good Pharmacovigilance Practice

HIPAA: Health Insurance Portability and Accountability Act

HRPP: Human Research Protection Program

IBC: Institutional Biosafety Committee

ICF: Informed Consent Form

ICH: International Council for Harmonization

IDE: Investigational Device Exemptions

IEC: Independent Ethics Committee

IHCRA: In House Clinical Research Associate

IIT: Investigator Initiated Trial

IND: Investigational New Drug (Application)

IP: Investigational Product

IRB: Institutional Review Board

ITT: Intent to Treat

IVRS: Interactive Voice Response System

IWRS: Interactive Web Response System

LTFU: Long Term Follow Up

LRAA: Local Regulatory Affairs Associate

MAC: Medicare Administrative Contractor

MAD: Multiple Ascending Dose

MCA: Medicare Coverage Analysis

Related webinar: Build a Better Budget: Using Medicare Coverage Analysis to Streamline Study Startup.

MRN: Medical Record Number

NCI: National Cancer Institute

NDA: New Drug Application

NHV: Normal Healthy Volunteer

NIH: National Institutes of Health

NLM: National Library of Medicine

OCT: Office of Clinical Trials

OHRP: Office for Human Research Protections

OSR: Outside Safety Report

PAC: Post Approval Commitments

PC: Protocol Coordinator

PD: Protocol Director

PHI: Protected Health Information

PI: Principal Investigator

PK/PD: Pharmacokinetic/Pharmacodynamic

PRE: Prompt Reporting Event

PRMC: Protocol Review and Monitoring Committee

PRMS: Protocol Review and Monitoring System

QC: Quality Control

QCT: Qualifying Clinical Trial

QMS: Quality Management System

SAD: Single Ascending Dose

SAE: Serious Adverse Event

SC: Study Coordinator

SDR: Source Document Review (Also Source Data Review)

SDTM: Study Data Tabulation Model

SDV: Source Document Verification

SIF: Site Investigator File

SMO: Site Management Organization

SOC: Standard of Care

SOE: Schedule of Events

SOP: Standard Operating Procedure

Related article: “Data Collection in Clinical Trials: 4 Steps for Creating an SOP”

SPOREs: Specialized Programs for Research Excellence

SRB: Scientific Review Board

SRC: Scientific Review Committee

SUSAR: Suspected Unexpected Serious Adverse Reaction

SVT: Subject Visit Template

TMF: Trial Master File (also eTMF)

TMO: Trial Management Organization

UADE: Unanticipated Adverse Device Effect

UADR: Unexpected Adverse Drug Reaction

UAP: Unanticipated Problem

Is there an abbreviation or acronym you see regularly in clinical research that isn’t listed here? Let us know.

To learn more about the fundamentals of clinical research, check out these free resources:

• Improve Data Quality with 5 Fundamentals of Clinical Data Management
• Beginner’s Guide to Clinical Trial Performance Metrics
• Deciphering the CRC Career Path: Key Skills and Responsibilities

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